Prospective Radiological Environmental Impact Assessment for Facilities and Activities

DS427 Draft Version 8.5 Date: 23 November 2016 IAEA SAFETY STANDARDS For protecting people and the environment Status: STEP 13 Endorsed by the CSS For submission to the PC Prospective Radiological Environmental Impact Assessment for Facilities and Activities DRAFT SAFETY GUIDE DS427 1

FOREWORD [Click here to insert foreword] 2

CONTENTS 1. INTRODUCTION... 5 Background... 5 Objective... 6 Scope 7 Structure... 10 2. EXPLANATION OF CONCEPTS AND TERMS... 11 Planned exposure situations: exposures expected to occur in normal operation and potential exposures... 11 Governmental decision making process... 11 Authorization process... 11 Environmental Impact Assessment... 12 Environment and protection of the environment... 12 Radiological Environmental Impact Assessment... 13 Members of the Public... 13 3. SAFETY REQUIREMENTS RELEVANT TO PROSPECTIVE RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENT... 14 Limitation of dose and constraint of dose and risk... 14 Assessment for protection of the public and protection of the environment... 14 Assessment and control of potential exposure... 15 Graded approach... 16 Transboundary impacts... 17 4. FRAMEWORK FOR PROSPECTIVE RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENT FOR FACILITIES AND ACTIVITIES... 18 Assessment for the authorization process... 18 Assessment as part of a governmental decision making process... 22 Assessments for other purposes... 23 Communication of results... 23 5. METHODOLOGY FOR THE ASSESSMENT... 25 General considerations... 25 Assessment for protection of the public in normal operation... 26 Approach to the assessment... 26 Selection of the source term... 27 Modelling of direct irradiation, dispersion and transfer in the environment... 28 Identification of exposure pathways... 31 Identification of the representative person for normal operation... 32 Assessment of the dose to the representative person... 33 Comparison of estimated doses with dose constraints and dose limits... 34 Assessment for protection of the public against potential exposures... 34 Approach to the assessment... 35 Identification and selection of potential exposure scenarios... 35 Selection of the source term... 36 Modelling of direct irradiation, dispersion and environmental transfer... 37 3

Identification of exposure pathways... 38 Identification of the representative person for potential exposures... 39 Assessment of the dose to the representative person for potential exposures... 40 Comparison of estimated doses and risks with criteria... 40 Considerations relating to the assessment of the protection of the environment... 42 6. CONSIDERATIONS ON VARIABILITY AND UNCERTAINTY IN RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENTS... 44 APPENDIX. RISK CRITERIA FOR THE ASSESSMENT OF POTENTIAL EXPOSURE OF THE PUBLIC... 47 REFERENCES... 49 ANNEX I. EXAMPLE OF A GENERIC METHODOLOGY FOR ASSESSING EXPOSURES OF FLORA AND FAUNA IN NORMAL OPERATION OF FACILITIES AND ACTIVITIES... 53 REFERENCES TO ANNEX I... 60 ANNEX II. CONSIDERATION ON THE RISK OF HEALTH EFFECTS AND THE ASSESSMENT OF POTENTIAL EXPOSURES... 63 REFERENCES TO ANNEX II... 67 CONTRIBUTORS TO DRAFTING AND REVIEW... 69 4

1. INTRODUCTION BACKGROUND 1.1. In 2014, the IAEA published the Safety Requirements: Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, General Safety Requirements Part 3 (GSR Part 3) [1]. GSR Part 3 [1] is based on the Fundamental Safety Principles (SF-1) [2] and the recommendations of the International Commission on Radiological Protection (ICRP) [3].The system of radiation protection and safety set out in GSR Part 3 [1] aims to assess, manage and control exposure to radiation so that radiation risks, including risks of health effects and risks to the environment, are reduced to the extent reasonably achievable. Protection of the public is based on the principles of justification, optimization and dose limitation, which were specified by the ICRP [3] and are incorporated in the IAEA Safety Standards [1, 2]. 1.2. GSR Part 3 [1] establishes a requirement for a prospective assessment to be conducted of the radiological environmental impacts due to releases of radionuclides from facilities and activities 1. This Safety Guide provides guidance on meeting the requirements in GSR Part 3 [1] for performing such assessments for certain facilities and activities if required by the regulatory body and, in particular, for meeting the requirement established in para. 3.9 (e) of GSR Part 3 [1], which states that Any person or organization applying for authorization: [ ] Shall, as required by the regulatory body, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity. 1.3. The aim of a prospective radiological environmental impact assessment is to determine whether the planned facility or activity complies with current legislative and regulatory requirements on protection of the public and protection the environment under all reasonably foreseeable circumstances. Such a prospective assessment includes the consideration of exposures expected to occur in normal operation and potential exposures due to accidents that are identified and characterized by mean of a safety analysis. The radiological environmental impact assessment should be as simple as possible, but as complex as necessary to achieve this aim. 1.4. In the framework of international legal instruments or national laws and regulations, States may also require that, for some activities or facilities, a governmental decision making process 2, including a comprehensive initial assessment of possible significant effects on the environment, is carried out at an early stage in the development of the facility or activity. In this case, the radiological environmental impact assessment is generally part of a broader impact assessment, which is generally referred to as an environmental impact assessment or by its common abbreviation EIA. An environmental impact assessment covers not only biophysical impacts, but also assesses prospectively social, economic and other relevant impacts of a proposed activity or facility prior to major decisions being taken. Within such a framework, the results of the radiological environmental impact assessment, as described 1 The term facilities and activities is defined in SF-1 [2] and the IAEA Safety Glossary [4]. It is a general term encompassing all nuclear facilities and uses of all sources of ionizing radiation. The recommendations of this Safety Guide apply to certain facilities and activities, as described in paras 1.10 to 1.24. 2 An explanation of the term governmental decision making process is provided in Section 2. 5

within this Safety Guide, may be used for making informed judgements on the acceptability of the risk from the radiation protection perspective. 1.5. This Safety Guide is related to other publications in the IAEA Safety Standards Series, namely the Safety Requirements for Safety Assessment for Facilities and Activities, IAEA Safety Standards Series No. GSR Part 4 (Rev. 1) [5] and for Preparedness and Response for a Nuclear or Radiological Emergency, IAEA Safety Standards Series No. GSR Part 7 [6], and the Safety Guides on Radiation Protection of the Public and the Environment, IAEA Safety Standards Series No. DS432 [7], on Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency, IAEA Safety Standards Series No. GSG-2 [8] and on Regulatory Control of Radioactive Discharges to the Environment, IAEA Safety Standards Series No. DS442 [9]. This Safety Guide should be used in conjunction with these other safety standards 3. 1.6. This Safety Guide provides a general framework that is consistent with and can be applied as a complement to the guidance provided in other Safety Guides setting out frameworks for safety assessment for facilities and activities, in which the concept of radiological environmental impact assessment is included as part of the safety assessment but where it is described in less detail; for example, in the frameworks described in The Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste, IAEA Safety Standards Series No. GSG-3 [13], and in Safety Assessment for the Decommissioning of Facilities Using Radioactive Material, IAEA Safety Standards Series No. WS-G-5.2 [14]. OBJECTIVE 1.7. This Safety Guide provides recommendations and guidance on a general framework for performing prospective radiological impact assessments for facilities and activities, to estimate and control the radiological effects on the public and on the environment. This radiological impact assessment is intended for planned exposure situations as part of the authorization process and, when applicable, as part of a governmental decision making process for facilities and activities. The situations covered include both exposures expected to occur in normal operation and potential exposures (see para 2.2). 1.8. This Safety Guide provides general guidance and recommendations about the content of a prospective radiological environmental impact assessment, its use and the procedures for its implementation, as an aid to national regulatory bodies, to persons or organizations responsible for facilities and activities and to other interested parties 4, including but not restricted to those persons or organizations applying for an authorization for or responsible for 3 The IAEA has also issued a Safety Report on methods and models that can be used to assess the impact of releases of radioactive material to the environment [10] and Technical Reports relevant to environmental transfer parameters [11,12]. A revision of Safety Reports Series No. 19 [10] is in preparation, and will cover screening assessments of public exposure; generic models and parameters for use in assessing the impact of radioactive discharges; and generic models and parameters for assessing exposures of flora and fauna due to radioactive discharges from facilities and activities. 4 GSR Part 3 [1] uses the term interested party to mean, in a broad sense, a person or group having an interest in the performance of an organization. Interested parties have typically included customers, owners, operators, employees, suppliers, partners, trade unions; the regulated industry or professionals; scientific bodies; governmental agencies or regulatory bodies. It could also include other States, e.g. neighbouring States concerned with possible transboundary impacts. 6

the operation of facilities and conduct of activities. It is recognized in this Safety Guide that different States use different approaches to perform some aspects of the radiological environmental impact assessment. This is due to the complexity and diversity of the options for management of environmental issues, which depends on the characteristics of the facilities and activities themselves, the environmental conditions and the national circumstances. 1.9. Figures 1 to 3 and I-1 and I-2 illustrate elements of such assessments and facilitate their description, but do not represent detailed procedures. Other important aspects that should be considered when performing a radiological environmental impact assessment, such as selection of computer codes, uncertainty analysis, verification, quality assurance and quality control, are not described in this Safety Guide. SCOPE 1.10. The Safety Guide applies to those facilities and activities for which, according to their characteristics and according to national or internationally applicable regulations, a radiological environmental impact assessment is mandatory. Guidance on how to determine the need for and complexity of a radiological environmental impact assessment is provided in Section 4. 1.11. This Safety Guide provides guidance on how to evaluate prospectively radiation exposures and radiation risks due to radioactive releases to the environment, and, when relevant, due to direct external irradiation, from new or existing facilities and activities, from which the public and the environment may be exposed to radiation 5. It describes a radiological environmental impact assessment using generic data and models and site specific data and models, and a combination of both, as relevant. 1.12. The radiation exposures considered include those that are expected to occur as a result of normal operation (i.e. due to authorized discharges or direct external irradiation) and also exposures that may occur but are not certain to occur, as determined by means of a safety analysis 6 of events and accidents 7, as defined in GSR Part 3 [1] (i.e. potential exposures). 1.13. This Safety Guide does not provide guidance on equivalent prospective assessments of delayed exposures that may occur in the post-closure period of a waste disposal facility [15], of exposures from the transport of radioactive material and of exposures from the use of mobile radioactive sources. Specific guidance on assessment of exposures for disposal and for 5 Facilities and activities needing radiological environmental impact assessment are those in which radioactive material is produced, processed, used, handled or stored in such a form and on such a scale that consideration of the possible impact on the public and the environment is required. Examples of such facilities are: nuclear installations (including nuclear power plants, research reactors, radioisotope production facilities and source production facilities, spent fuel storage facilities and reprocessing facilities, facilities for the enrichment of uranium, nuclear fuel fabrication facilities, predisposal radioactive waste management facilities, disposal facilities during the operational period and nuclear fuel cycle related research and development facilities); some mining and raw material processing facilities, such as open-pit uranium mines; and facilities for the milling or processing of uranium ores. Examples of activities include: the use of unsealed radiation sources for industrial, research and medical purposes, and the decommissioning of certain facilities. 6 Safety analysis is part of the safety assessment for facilities and activities [5]. 7 The IAEA Safety Glossary defines an accident as any unintended event, including operating errors, equipment failures and other mishaps, the consequences or potential consequences of which are not negligible from the point of view of protection or safety [4]. 7

transport is provided in The Safety Case and Safety Assessment for the Disposal of Radioactive Waste, IAEA Safety Standards Series No. SSG-23 [16] and in Radiation Protection Programmes for the Transport of Radioactive Material, IAEA Safety Standards Series No. TS-G-1.3 [17], respectively. 1.14. A radiological environmental impact assessment, as described within this Safety Guide, is intended to be prospective in nature. For example, it can be conducted prior to siting, as part of the application for an authorization during construction and prior to operation, or prior to decommissioning. A radiological environmental impact assessment can serve multiple purposes, including establishing the initial basis for authorization with respect to protection of the public and protection of the environment, and as an important input into the process of authorizing controlled discharges. The process for authorizing discharge limits for optimizing the protection of workers and the public and safety is covered in DS442 [9]. 1.15. A radiological environmental impact assessment can also be conducted for those existing facilities for which changes in their operational processes are planned before the implementation of any significant change affecting the level of discharges or potential releases to the environment; if deemed necessary, a radiological environmental impact assessment can also be conducted in the framework of a periodic safety review. 1.16. The radiological environmental impact assessment described in this Safety Guide is not intended to assess retrospectively the radiological impact from discharges during operation or the consequences of an actual accident. Nevertheless, the prospective assessment of potential exposures could provide preliminary information to be used in assessing the hazards and the related consequences for the purpose of establishing an adequate level of emergency preparedness and response [6]. 1.17. The prospective assessment of potential exposures for facilities and activities, as described in this Safety Guide, may necessitate that accidents with very low probabilities of occurrence leading to radiological consequences for the public and the environment are considered and the criteria for potential exposures are met. However, even if a facility or an activity meets these criteria, it does not preclude the need for an assessment of hazards in relation to preparedness and response for a nuclear or radiological emergency, in line with requirements in GSR Part 7 [6]. Other aspects of the consequences of large accidental releases to the environment, such as societal and economic effects and non-radiological effects on the environment and on ecosystems, are outside the scope of this Safety Guide. 1.18. This Safety Guide does not describe in detail the specifications and characteristics of the events and accidents to be considered in the assessment of potential exposure of the public, nor the methodology for their selection and analysis; such specification and characterization, which should be determined by a systematic analysis, should be done in the framework of a safety assessment for facility or activity, as described in GSR Part 4 (Rev. 1) [5]. 1.19. This Safety Guide defines a general framework and describes the general aspects of the methodology for performing a prospective radiological environmental impact assessment, and does not describe in detail the models to be used or the collection and use of data from radiological environmental monitoring programmes, which are normally undertaken at the 8

pre-operational stage and the operational stage 8 of a facility or activity. For the purposes of this Safety Guide, it is assumed that environmental and source monitoring is carried out as relevant at the pre-operational stage and the operational stage and that it provides the necessary information for adequate dose estimations and for verifying that the models and assumptions used in the prospective assessment are appropriate. The prospective assessment as described in this Safety Guide can also be used to underpin the establishment or upgrade of a site specific environmental monitoring programme. Guidance for environmental and source monitoring programmes is provided in Environmental and Source Monitoring for Purposes of Radiation Protection, IAEA Safety Standards Series No. RS-G-1.8 [18] and further information is provided in Ref. [19]. The need for and general characteristics of environmental monitoring programmes for demonstration of compliance with authorized discharge limits are addressed in DS442 [9]. 1.20. This Safety Guide does not cover occupational exposures or medical exposures. Recommendations on these categories of exposure and their inclusion in the authorization process are provided in Occupational Radiation Protection, IAEA Safety Standards Series No. DS453 [20] and Radiation Protection and Safety in Medical Uses of Ionizing Radiation, IAEA Safety Standards Series No. DS399 [21]. 1.21. This Safety Guide covers primarily the assessment of the risk of radiological impacts to the health of individual members of the public due to radiation exposure during normal operation and due to potential exposure, as required by GSR Part 3 [1]. In many instances, it can be concluded, on the basis of evidence such as experience or simplified analysis, that specific consideration of effects in the environment is not necessary. This may not be the case in all situations and the explicit consideration of protection of the environment may be required by the regulatory body. In other cases, explicit consideration of protection of the environment is captured in national legislation. A methodology for the explicit assessment of the radiation impacts on flora and fauna, which can be used in accordance with national or international regulatory frameworks for protection of the environment, is presented as an example in Annex I. 1.22. This Safety Guide does not address the process of iteration and design optimization, which is normally conducted within the framework of a safety assessment for the predisposal management of radioactive waste [13]; however a radiological environmental impact assessment as described in this Safety Guide may serve as an input for that process. 1.23. Optimization of protection and safety is required in GSR Part 3 [1]; the optimization process includes not only consideration of the protection of the public, but also consideration of the protection of workers and all the safety features of the facility or activity, such as those related to the on-site management of radioactive waste. This Safety Guide covers the assessment of the exposure of the public only. The wider aspects of optimization of protection and safety are covered in other IAEA Safety Standards, for example in GSG-3 [13] on predisposal management of radioactive waste. Optimization of the protection of the public in connection with the establishment of radioactive discharge limits for facilities and activities is 8 Monitoring programmes at the pre-operational stage are defined, for instance, to establish baseline activity concentrations in environmental media and to provide information and data for dose assessment purposes [18]. During the operation of the facility or the conduct of the activity, monitoring programmes are put in place to verify compliance with discharge limits, to check the conditions of operation, to provide warning of unusual or unforeseen conditions and to check the predictions of environmental models [18]. 9

described in DS442 [9]. The result of a radiological environmental impact assessment, as described in this Safety Guide, is a necessary input to the optimization process to be used for establishing discharge limits. 1.24. The possible non-radiological impacts of facilities and activities, which are generally included in an environmental impact assessment, such as the impacts on people and the environment from releases of other hazardous substances (i.e. chemicals and heated water), the impacts from the construction of a facility, the impacts on places of societal significance (i.e. historical monuments and cultural places), the impacts on endangered species, the impacts on the landscape, as well as other societal and economic factors, are not considered in this Safety Guide but should be considered by States at the time of making relevant decisions. STRUCTURE 1.25. Section 2 provides explanations of the main concepts and terms used in the Safety Guide. Section 3 presents the safety requirements for the government, the regulatory body and licensees relating to prospective radiological environmental impact assessment. Section 4 describes the framework in which such assessments are done. Section 5 describes the methodology needed to carry out a prospective radiological environmental impact assessment for protection of the public for normal operation and for potential exposures, and addresses the protection of the environment. The Appendix presents risk criteria established by relevant international organizations, which could be used as the basis to define national criteria for consideration of potential exposures. Annex I presents an example of a methodology for assessing and controlling the exposures of flora and fauna. Annex II presents considerations on the risk of health effects and the assessment of potential exposure of the public. 10

2. EXPLANATION OF CONCEPTS AND TERMS 2.1. This section provides an explanation of some of the concepts and terms used in this Safety Guide. Unless otherwise mentioned, concepts or terms are to be understood as defined in GSR Part 3 [1] or in the IAEA Safety Glossary [4]. PLANNED EXPOSURE SITUATIONS: EXPOSURES EXPECTED TO OCCUR IN NORMAL OPERATION AND POTENTIAL EXPOSURES 2.2. Paragraph 1.20 (a) of GSR Part 3 defines a planned exposure situation as a situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure due to a source In planned exposure situations, exposure at some level can be expected to occur. If exposure is not expected to occur with certainty, but could result from an accident or from an event or a sequence of events that may occur but is not certain to occur, this is referred to as potential exposure [1]. The magnitude and extent of these exposures can usually be predicted. Both exposures expected to occur and potential exposures can and should be taken into account at the planning or design stage [7]. GOVERNMENTAL DECISION MAKING PROCESS 2.3. In the context of this Safety Guide the term governmental decision making process refers to the procedures carried out at all planning, pre-operational, operational and decommissioning stages by the government or governmental agencies, including the regulatory body, in deciding whether a project for a facility or an activity may be undertaken, continued, changed or stopped. The term could also apply to areas of national policy, such as whether to embark on a nuclear power programme [22]. 2.4. A governmental decision making process is normally conducted at the early stages of a programme of development and, mainly, for activities or facilities for which it is foreseen that a thorough assessment of their possible impact on the environment is necessary. For some nuclear installations and facilities, this decision making process is described in national or international regulations by the term environmental impact assessment 9 (see paras 2.7 to 2.9). AUTHORIZATION PROCESS 2.5. Authorization is defined in GSR Part 3 as The granting by a regulatory body or other governmental body of written permission for a person or organization (the operator) to conduct specified activities [1]. 2.6. The authorization for a facility or an activity, in the form of registration or licence [1], could be granted for the design, siting, construction and operation of the facility or activity, 9 The term governmental decision making process encompasses or is related to different terms used in some States with similar or equivalent meanings, such as decision in principle, environmental impact statement, and, in some cases, justification. 11

for decommissioning activities and when modifications in the conditions of operation of the facility or the conduct of the activity are considered. ENVIRONMENTAL IMPACT ASSESSMENT 2.7. The term environmental impact assessment is included in many international instruments and national legislation and regulations [23 30]. In the context of this Safety Guide, an environmental impact assessment refers to a procedure within a governmental decision making process for identifying, describing and assessing prospectively the effects and the risk of effects of a particular proposed activity or facility on aspects of environmental significance 10. 2.8. The effects relating to radioactive releases from facilities and activities to the environment likely to be considered in an environmental impact assessment generally include radiological effects on human health and, where required by States, radiological effects on flora and fauna. Non-radiological impacts included in an environmental impact assessment are not considered in this Safety Guide but are subject to national and internationally applicable regulations. 2.9. In general, an environmental impact assessment requires the involvement of the applicant of the proposed activity or facility, relevant governmental agencies, the regulatory body and a number of interested parties, including, in some States, the public [22-30]. ENVIRONMENT AND PROTECTION OF THE ENVIRONMENT 2.10. GSR Part 3 [1] defines the environment as The conditions under which people, animals and plants live or develop and which sustain all life and development; especially such conditions as affected by human activities. Usually, the environment includes ecosystems that comprise biotic and abiotic components. 2.11. GSR Part 3 [1] further states in the definition of the environment that Protection of the environment includes protection and conservation of: non-human species, both animal and plant, and their biodiversity; environmental goods and services, such as the production of food and feed; resources used in agriculture, forestry, fisheries and tourism; amenities used in spiritual, cultural and recreational activities; media such as soil, sediments, water and air; and natural processes, such as carbon, nitrogen and water cycles. 2.12. Furthermore, the introduction of GSR Part 3 [1] in para. 1.35 notes that the protection of the environment [is identified] as an issue necessitating assessment, while allowing for flexibility in incorporating into decision making processes the results of environmental assessments that are commensurate with the radiation risks [1]. 10 Reference [31] provides information on environmental impact assessment in the framework of the development of a new nuclear power programme. 12

RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENT 2.13. For the purpose of this Safety Guide, a radiological environmental impact assessment is a prospective assessment of the expected and analytically conceivable radiological impacts, which is quantified in terms of effective dose to members of the public, and which is conducted as part of the authorization process. The results of a radiological environmental impact assessment are compared with predefined radiological criteria defined in GSR Part 3 [1]. A radiological environmental impact assessment may be seen as one component of an environmental impact assessment (as described in paras 2.7 to 2.9) in the context of planning for a particular facility or activity. MEMBERS OF THE PUBLIC 2.14. GSR Part 3 [1] defines a member of the public as in a general sense, any individual in the population except when subject to occupational exposure or medical exposure. SF-1, Principle 7 (Protection of present and future generations), states that Safety standards apply not only to local populations but also to populations remote from facilities and activities. In addition, Where effects could span generations, subsequent generations have to be adequately protected without any need for them to take significant protective actions [2]. 13

3. SAFETY REQUIREMENTS RELEVANT TO PROSPECTIVE RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENT 3.1. This section contain extracts from the SF-1 [2], GSR Part 3 [1] and GSR Part 4 [5] setting out the relevant safety requirements for protection of the public and protection of the environment that are required to be considered in the conduct of prospective radiological environmental assessments for planned exposure situations. Recommendations on how to meet these requirements are provided in Sections 4 and 5 and in the Appendix of this Safety Guide. LIMITATION OF DOSE AND CONSTRAINT OF DOSE AND RISK 3.2. SF-1 [2] establishes principles for ensuring the protection of the public and the environment, now and in the future, from harmful effects of ionizing radiation, and states under Principle 6 (Limitation of risk to individuals) that doses and radiation risks must be controlled within specified limits (para 3.25). These principles apply to situations involving exposure to, or the potential for exposure to, ionizing radiation 11. 3.3. GSR Part 3 [1] states that, for planned exposure situations, exposures of and risk to members of the public are required to be subject to control (paras 2.11, 3.26, 3.27, 3.120 (c) and 3.123 (b)). 3.4. Requirement 12 of GSR Part 3 [1] states that The government or the regulatory body shall establish dose limits for public exposure, and registrants and licensees shall apply these limits. 3.5. Paragraph 3.120 of GSR Part 3 [1], which relates to responsibilities specific to public exposure, states that The government or the regulatory body shall establish or approve constraints on dose and constraints on risk to be used in the optimization of protection and safety for members of the public. Paragraph 3.123 of GSR Part 3 [1] states that The regulatory body shall establish or approve operational limits and conditions relating to public exposure, including authorized limits for discharges. These operational limits and conditions: [ ] (e) Shall take into account the results of the prospective assessment for radiological environmental impacts that is undertaken in accordance with requirements of the regulatory body [ ]. ASSESSMENT FOR PROTECTION OF THE PUBLIC AND PROTECTION OF THE ENVIRONMENT 3.6. Principle 7 of SF-1 [2] states that: People and the environment, present and future, must be protected against radiation risks. 11 The principle of dose and risk limitation is not applied to emergency exposures situations and existing exposures situation, for which reference levels are used instead. 14

3.7. Paragraph 3.28 of SF-1 [2] states that The present system of radiation protection generally provides appropriate protection of ecosystems in the human environment against harmful effects of radiation exposure. The general intent of the measures taken for the purposes of environmental protection has been to protect ecosystems against radiation exposure that would have adverse consequences for populations of a species (as distinct from individual organisms). 3.8. Paragraph 3.9 of GSR Part 3 [1] states that Any person or organization applying for authorization: [ ] (e) Shall, as required by the regulatory body, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity. Section 4 of this Safety Guide provides guidance on the context in which an assessment is done and Section 5 describes the methodology for assessment of the level of protection of the public and the environment. 3.9. Paragraph 3.15 of GSR Part 3 [1] establishes the responsibilities of registrants and licensees in planned exposure situations. It states that Registrants and licensees: [ ] (d) Shall, for the sources for which they are authorized and for which the regulatory body requires a prospective assessment to be made for radiological environmental impacts, conduct such an assessment and keep it up to date. 3.10. Requirement 31 of GSR Part 3 [1] relates to radioactive waste and discharges. Paragraph 3.132 of GSR Part 3 [1] states that: Registrants and licensees, in cooperation with suppliers, in applying for an authorization for discharges, as appropriate: (a) Shall determine the characteristics and activity of the material to be discharged, and the possible points and methods of discharge; (b) Shall determine by an appropriate pre-operational study all significant exposure pathways by which discharged radionuclides could give rise to exposure of members of the public; (c) Shall assess the doses to the representative person due to the planned discharges; (d) Shall consider the radiological environmental impacts in an integrated manner with features of the system of protection and safety, as required by the regulatory body. ASSESSMENT AND CONTROL OF POTENTIAL EXPOSURE 3.11. Paragraph 3.15 (e) of GSR Part 3 [1] states that: Registrants and licensees: [ ] (e) Shall assess the likelihood and magnitude of potential exposures, their likely consequences and the number of persons who may be affected by them. 15

3.12. Paragraph 3.24 of GSR Part 3 [1] states that: Registrants and licensees shall ensure that all relevant factors are taken into account in a coherent way in the optimization of protection and safety to contribute to achieving the following objectives: (a) To determine measures for protection and safety that are optimized for the prevailing circumstances, with account taken of the available options for protection and safety as well as the nature, likelihood and magnitude of exposures; (b) To establish criteria, on the basis of the results of the optimization, for the restriction of the likelihood and magnitudes of exposures by means of measures for preventing accidents and for mitigating the consequences of those that do occur. 3.13. Requirement 6 of GSR Part 4 (Rev. 1) [5] states that The possible radiation risks associated with the facility or activity shall be identified and assessed. These include the level and likelihood of radiation exposure of [ ] the public, and of the possible release of radioactive material to the environment, that are associated with anticipated operational occurrences or with accidents that lead to a loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or any other source of radiation. 3.14. Paragraph 3.31 of GSR Part 3, [1] states that: Safety assessment shall be conducted [ ] so as: (a) To identify the ways in which exposures could be incurred [...]; (b) To determine the expected likelihood and magnitudes of exposures in normal operations and, to the extent reasonable and practicable, make an assessment of potential exposures. GRADED APPROACH 3.15. Paragraph 3.24 of SF-1 [2] states that The resources devoted to safety by the licensee, and the scope and stringency of the regulations and their application, have to be commensurate with the magnitude of the possible radiation risks and their amenability to control. 3.16. Paragraph 3.1 of GSR Part 4 (Rev. 1) [5] states that to apply Principle 5 of SF-1 (Optimization of Protection) a graded approach shall be taken in carrying out the safety assessments for the wide range of facilities and activities owing to the very different levels of possible radiation risks associated with them. 3.17. Requirement 6 of GSR Part 3 [1] states that The application of the requirements of these Standards in planned exposure situations shall be commensurate with the characteristics of the practice or the source within a practice, and with the likelihood and magnitude of the exposures. 3.18. Paragraph 3.4 of GSR Part 4 (Rev. 1) [5] states that Other relevant factors, such as the maturity or complexity of the facility or activity, shall also be taken into account in a graded approach to safety assessment. GSR Part 4 (Rev.1) [5] also states (paragraph. 3.6) that The application of the graded approach shall be reassessed as the safety assessment progresses and 16

a better understanding is obtained of the radiation risks arising from the facility or activity. The scope and level of detail of the safety assessment are then modified as necessary and the level of resources to be applied is adjusted accordingly. TRANSBOUNDARY IMPACTS 3.19. Requirement 29 of GSR Part 3 [1] addresses the issue of exposure outside the territory of the State in which the source is located 12. Paragraph 3.124 of GSR Part 3 [1] states that: When a source within a practice could cause public exposure outside the territory or the area under the jurisdiction or control of the State in which the source is located, the government or the regulatory body: (a) Shall ensure that the assessment of the radiological impacts includes those impacts outside the territory or other area under the jurisdiction or control of the State; [ ] (c) Shall arrange with the affected State the means for exchange of information and consultations, as appropriate. 12 The consideration of the protection of public and protection of the environment from possible transboundary impacts and the obligations for assessing the impacts and sharing information between States should also be addressed within the broader context of relevant international agreements and conventions (e.g. Espoo 1991 [23], UNCLOS 1982 [24], Aarhus 1998 [25] and Article 37 of the EURATOM Treaty [32]). 17

4. FRAMEWORK FOR PROSPECTIVE RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENT FOR FACILITIES AND ACTIVITIES 4.1. The government or the regulatory body should specify in advance the types of facility and activity for which a radiological environmental impact assessment is required or should specify criteria for deciding, on a case-by-case basis, whether such an assessment is needed. In general, such an assessment should not be required for X ray generators, small laboratories, diagnostic radiology, industrial applications using sealed sources, and any other facilities or activities where radiation sources or generators are used, processed or stored in a form and at a scale that impacts on the public and the environment are not expected in normal operation or accidents. 4.2. The required level of complexity of the radiological environmental impact assessment should also be defined by the government or the regulatory body in the national legal framework or regulations. Account should be taken on the characteristics of the activity or facility, based on considerations of the risk to the public and the environment due to exposures expected in normal operation and potential exposures. Facilities and activities that are exempted 13 without further consideration should not require a radiological environmental impact assessment for authorization, even if a generic assessment of the impact on the public and the environment may have been performed to support the conclusion on exemption. Where exemption is granted subject to conditions, the need for a radiological environmental impact assessment should be considered. 4.3. The methods used to perform a radiological environmental impact assessment (e.g. the assumptions, the conceptual models, the mathematical models and the input data) may differ according to the complexity of the facility or activity and the associated exposure scenarios, and should be selected by taking into account the requirements for a graded approach. In general, it is often more practical to start with a simple conservative assessment, using, for example, generic input data and assuming a cautious exposure scenario according to which the public and the environment are exposed to ionizing radiation, and then to increase the complexity of the assessment as necessary, for instance, using site specific data and more detailed and realistic exposure scenarios, until a clear and defensible conclusion is reached. For the sake of clarity, assessments described in this Safety Guide are sometimes categorized as either simple or complex. However, these terms are intended to convey the two ends of a range of possible assessments and there are a large number of activities and facilities for which an assessment falling between these two types will be appropriate. ASSESSMENT FOR THE AUTHORIZATION PROCESS 4.4. Factors that are important for determining the need for and complexity of the radiological environmental impact assessment within an authorization process include the following: the source term 14 ; the expected doses; the characteristics of the activity or facility; 13 The concept of exemption and the general criteria for exemption of practices are set out in schedule I of GSR Part 3 [1]. 14 The source term is the amount and isotopic composition of material released (or postulated to be released) from a facility and the concept is used in modelling releases of radionuclides to the environment [4]. It is also 18

the characteristics of the location; the national licensing regulations for the particular facility or activity; and the stage in the authorization process (see Table 1). The applicant should consider those factors when submitting an application to the regulatory body for review and agreement. For certain facilities or activities, the level of detail of the assessment can be defined a priori by the regulatory body. 4.5. The factors and elements set out in Table 1 should be used as general guidance as to whether a simple or complex radiological environmental impact assessment might be appropriate 15. In general, an assessment in support of the authorization of a nuclear facility will require a high degree of complexity, while for an activity or facility operating with a small inventory of radionuclides, a simpler analysis may be justified. TABLE 1. EXAMPLES OF FACTORS AFFECTING THE REQUIRED LEVEL OF COMPLEXITY OF A PROSPECTIVE RADIOLOGICAL ENVIRONMENTAL IMPACT ASSESSMENT Factor Characteristics of the facility or activity Characteristics of the location Source term Expected doses from normal operation or projected doses from potential exposures Safety characteristics of the activity or facility Characteristics of the authorization process for the particular activity or facility Element Radionuclides Quantity (both activity and mass/volume) Form (chemical/physical make up) Geometry (size, shape, height of release) Potential for release: the source term differs significantly for normal operation and for accidents Preliminary assessments or previous assessments for similar facilities Types of safety barriers and engineering features present in the design Potential for severe accidents Characteristics of the facility site relating to dispersion of radionuclides in the environment (for example, geology, hydrology, meteorology, morphology, biophysical characteristics) Presence and characteristics of receptors (for example, demography, living habits and conditions, flora and fauna) Exposure pathways Land use and other activities (for example agriculture, food processing, other industries) Characteristics of other installations in the vicinity and possible natural and human induced external events (for example, earthquakes, flooding, industrial accidents, transport accidents) Requirements or regulations (licensing requirements) Stage of the authorization process applicable to certain activities and, together with the physical and chemical properties of the material released, can be relevant for modelling environmental dispersion. 15 The list provided in Table 1 is not exhaustive, and judgement on the significance of these factors when selecting the type of assessment will need to be made by experts in nuclear and radiation safety in the applicant s organization and by the national regulatory body. 19

4.6. For facilities or activities with relatively standardized practices, small inventories of radionuclides and a low potential for accidental releases to the environment, but which still can produce some impact on the public and the environment, for example, a hospital with a nuclear medicine department, the regulatory body may provide generic guidance identifying the necessary elements that should be included in the radiological environmental impact assessment. 4.7. For nuclear installations, for example nuclear power plants and nuclear fuel reprocessing facilities, there are likely to be a number of stages in the authorization process [33]. During these stages, the radiological environmental impact assessment may be updated as more specific data are obtained; the applicant or the operating organization of the installation should ensure that the updates of the results of the radiological environmental impact assessment are provided at each different stage, for consideration by the regulatory body. 4.8. Figure 1 has been adapted and modified from figure 1 in SSG-12 [33] and it presents schematically the stages in the lifetime of a nuclear installation. The radiological environmental impact assessments conducted prior to and during the operation of a nuclear installation will all be very similar, although they will incorporate successively more detail and specific data to reduce the level of uncertainty, where possible, and a review of the models and assumptions used, when this is deemed necessary. The vertical arrows in full in Fig. 1 indicate the point at which the radiological environmental impact assessment may be submitted to the regulatory body for discussion and, finally, submitted for approval, prior to the start of operation of the facility or the start of decommissioning. The vertical dashed lines indicate where an updated assessment may be submitted to the regulatory body if there are significant changes in the postulated level of releases or the potential exposure scenarios in the operational stage. The horizontal arrow indicates the evolution of time. FIG. 1. Stages in the lifetime of a nuclear installation where a prospective radiological environmental impact assessment might provide input into the authorization process. 20

4.9. An initial radiological environmental impact assessment that makes use of generic data should be conducted during the stage of siting and site evaluation to identify potential regions or sites for the facility or activity. This assessment should include site characteristics and regional characteristics that could affect safety, the exposure of people, current and future land use, considerations of cultural significance and economic significance, and demographic considerations. At this stage, different designs of the facility may still be under scrutiny and the information available on the systems and safety analyses of the design may be limited. 4.10. Once a site or a number of sites have been shortlisted and the design of the facility is more clearly defined, a preliminary radiological environmental impact assessment for the particular location(s) should be carried out using available site specific data. In general, during the construction period more information relevant for the assessment should be collected, including, where this is deemed necessary, the results of environmental measurements and results from surveys on living habits and conditions carried out at and around the site. The assessment should be refined as the project evolves and more information becomes available, in order to be able to produce a well substantiated final radiological environmental impact assessment at some point in the commissioning stage, before the operating organization submits its final application for authorization to the regulatory body. SSG-16 [22] provides guidance on the submission and updating of a radiological environmental impact assessment in the framework of establishing the safety infrastructure for a nuclear power programme. 4.11. The radiological environmental impact assessment performed before the start of the operation of a facility or conducting an activity should be used as one of the inputs to determine authorized discharge limits and any other operational quantities relating to protection of the public. Guidance on establishment of authorized discharge limits is presented in DS442 [9]. 4.12. For facilities already in operation and activities being conducted, the safety assessment should be periodically reviewed and updated at predefined intervals, in accordance with regulatory requirements [5]; this review should include the consideration of possible changes in the assumptions used to perform the radiological environmental impact assessment and the results of source monitoring and environmental monitoring programmes conducted during operation. The radiological environmental impact assessment may need to be revised if there are significant changes in characteristics of the facility or activity or in the characteristics of the location (see Table 1). 4.13. A prospective radiological environmental impact assessment carried out for a new installation should take account of the contribution to public exposures due to other facilities already operating or planned to be constructed at the site or the vicinity of the site under consideration. 4.14. Prior to the conduct of decommissioning actions, for certain facilities and activities such as nuclear installations, radioactive waste management facilities and uranium mining and milling facilities, a prospective radiological environmental impact assessment should be conducted for planning purposes [34]. 4.15. Before release of a site from regulatory control after decommissioning, a review of the radiological environmental impact assessment could be necessary, depending on the final radiological conditions of the former facility. However, for most facilities and activities after decommissioning, typically, exposures expected to occur and potential exposures will be 21